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Brain Communications 2024Disorders of consciousness are neurological conditions characterized by impaired arousal and awareness of self and environment. Behavioural responses are absent or are... (Review)
Review
Disorders of consciousness are neurological conditions characterized by impaired arousal and awareness of self and environment. Behavioural responses are absent or are present but fluctuate. Disorders of consciousness are commonly encountered as a consequence of both acute and chronic brain injuries, yet reliable epidemiological estimates would require inclusive, operational definitions of the concept, as well as wider knowledge dissemination among involved professionals. Whereas several manifestations have been described, including coma, vegetative state/unresponsive wakefulness syndrome and minimally conscious state, a comprehensive neurobiological definition for disorders of consciousness is still lacking. The scientific literature is primarily observational, and studies-specific aetiologies lead to disorders of consciousness. Despite advances in these disease-related forms, there remains uncertainty about whether disorders of consciousness are a disease-agnostic unitary entity with a common mechanism, prognosis or treatment response paradigm. Our knowledge of disorders of consciousness has also been hampered by heterogeneity of study designs, variables, and outcomes, leading to results that are not comparable for evidence synthesis. The different backgrounds of professionals caring for patients with disorders of consciousness and the different goals at different stages of care could partly explain this variability. The Prospective Studies working group of the Neurocritical Care Society Curing Coma Campaign was established to create a platform for observational studies and future clinical trials on disorders of consciousness and coma across the continuum of care. In this narrative review, the author panel presents limitations of prior observational clinical research and outlines practical considerations for future investigations. A narrative review format was selected to ensure that the full breadth of study design considerations could be addressed and to facilitate a future consensus-based statement (e.g. via a modified Delphi) and series of recommendations. The panel convened weekly online meetings from October 2021 to December 2022. Research considerations addressed the nosographic status of disorders of consciousness, case ascertainment and verification, selection of dependent variables, choice of covariates and measurement and analysis of outcomes and covariates, aiming to promote more homogeneous designs and practices in future observational studies. The goal of this review is to inform a broad community of professionals with different backgrounds and clinical interests to address the methodological challenges imposed by the transition of care from acute to chronic stages and to streamline data gathering for patients with disorders of consciousness. A coordinated effort will be a key to allow reliable observational data synthesis and epidemiological estimates and ultimately inform condition-modifying clinical trials.
PubMed: 38344653
DOI: 10.1093/braincomms/fcae022 -
BMJ Open Oct 2023The objective of this review is to (1) identify barriers and facilitators with respect to women's health services at a primary care level based on a systematic review...
OBJECTIVES
The objective of this review is to (1) identify barriers and facilitators with respect to women's health services at a primary care level based on a systematic review and narrative synthesis and (2) to conclude with recommendations for better services and uptake.
DESIGN
Systematic review and narrative synthesis.
DATA SOURCES
PubMed, BMC Medicine, Medline, CINAHL and the Cochrane Library. Grey literature was also searched.
ELIGIBILITY CRITERIA
Qualitative, quantitative and mixed studies were included in the review.
DATA EXTRACTION AND SYNTHESIS
The search took place at the beginning of June 2021 and was completed at the end of August 2021. Studies were included in the review based on the Sample, Phenomenon of Interest, Design, Evaluation, Research type criteria. The quality of the included studies was assessed using the Mixed Methods Appraisal Tool. Data were synthesised using a narrative synthesis approach.
RESULTS
A total of 33 studies were included in the review. We identified six barriers to the delivery of effective primary healthcare for women's health which have been organised under two core themes of 'service barriers' and 'family/cultural barriers'. Ten barriers to the uptake of primary healthcare for women have been identified, under three core themes of 'perceptions about healthcare service', 'cultural factors' and 'practical issues'. Three facilitators of primary healthcare delivery for women were identified: 'motivating community health workers (CHWs) with continued training, salary, and supervision' and 'selection of CHWs on the basis of certain characteristics'. Five facilitators of the uptake of primary healthcare services for women were identified, under two core themes of 'development of trust and acceptance' and 'use of technology'.
CONCLUSIONS
Change is needed not only to address the limitations of the primary healthcare services themselves, but also the cultural practices and limited awareness and literacy that prevent the uptake of healthcare services by women, in addition to the wider infrastructure in terms of the provision of financial support, public transport and child care centres.
PROSPERO REGISTRATION NUMBER
CRD42020203472.
Topics: Female; Humans; Pakistan; Health Services; Primary Health Care
PubMed: 37899162
DOI: 10.1136/bmjopen-2023-076883 -
Prostate Cancer and Prostatic Diseases Jun 2023Black men are twice as likely to be diagnosed with prostate cancer than White men. Raised prostate-specific antigen (PSA) levels can indicate an increased risk of... (Review)
Review
INTRODUCTION
Black men are twice as likely to be diagnosed with prostate cancer than White men. Raised prostate-specific antigen (PSA) levels can indicate an increased risk of prostate cancer, however it is not known whether PSA levels differ for men of different ethnic groups.
METHODS
PubMed and Embase were searched to identify studies that reported levels of PSA for men of at least two ethnic groups without a prostate cancer diagnosis or symptoms suggestive of prostate cancer. An adaptation of the Newcastle-Ottawa scale was used to assess risk of bias and study quality. Findings were stratified into the following broad ethnic groups: White, Black, Asian, Hispanic, and Other. Data were analysed in a narrative synthesis due to the heterogeneity of reported PSA measures and methods in the included studies.
RESULTS
A total of 654 197 males from 13 studies were included. By ethnicity, this included 536 201 White (82%), 38 287 Black (6%), 38 232 Asian (6%), 18 029 Pacific Island (3%), 13 614 Maori (2%), 8 885 Hispanic (1%), and 949 Other (<1%) men aged ≥40 years old. Black men had higher PSA levels than White men, and Hispanic men had similar levels to White men and lower levels than Black men.
CONCLUSIONS
Black men without prostate cancer have higher PSA levels than White or Hispanic men, which reflects the higher rates of prostate cancer diagnosis in Black men. Despite that, the diagnostic accuracy of PSA for prostate cancer for men of different ethnic groups is unknown, and current guidance for PSA test interpretation does not account for ethnicity. Future research needs to determine whether Black men are diagnosed with similar rates of clinically significant prostate cancer to White men, or whether raised PSA levels are contributing to overdiagnosis of prostate cancer in Black men.
Topics: Adult; Humans; Male; Prostate; Prostate-Specific Antigen; Prostatic Neoplasms; Racial Groups; Ethnicity
PubMed: 36456698
DOI: 10.1038/s41391-022-00613-7 -
Canadian Journal of Anaesthesia =... Oct 2023Randomized controlled trials are one of the best ways of quantifying the effectiveness of medical interventions. Therefore, when the authors of a randomized superiority...
Randomized controlled trials are one of the best ways of quantifying the effectiveness of medical interventions. Therefore, when the authors of a randomized superiority trial report that differences in the primary outcome between the intervention group and the control group are "significant" (i.e., P ≤ 0.05), we might assume that the intervention has an effect on the outcome. Similarly, when differences between the groups are "not significant," we might assume that the intervention does not have an effect on the outcome. Nevertheless, both assumptions are frequently incorrect.In this article, we explore the relationship that exists between real treatment effects and declarations of statistical significance based on P values and confidence intervals. We explain why, in some circumstances, the chance an intervention is ineffective when P ≤ 0.05 exceeds 25% and the chance an intervention is effective when P > 0.05 exceeds 50%.Over the last decade, there has been increasing interest in Bayesian methods as an alternative to frequentist hypothesis testing. We provide a robust but nontechnical introduction to Bayesian inference and explain why a Bayesian posterior distribution overcomes many of the problems associated with frequentist hypothesis testing.Notwithstanding the current interest in Bayesian methods, frequentist hypothesis testing remains the default method for statistical inference in medical research. Therefore, we propose an interim solution to the "significance problem" based on simplified Bayesian metrics (e.g., Bayes factor, false positive risk) that can be reported along with traditional P values and confidence intervals. We calculate these metrics for four well-known multicentre trials. We provide links to online calculators so readers can easily estimate these metrics for published trials. In this way, we hope decisions on incorporating the results of randomized trials into clinical practice can be enhanced, minimizing the chance that useful treatments are discarded or that ineffective treatments are adopted.
Topics: Humans; Bayes Theorem; Research Design; Biomedical Research; Benchmarking; Randomized Controlled Trials as Topic
PubMed: 37794259
DOI: 10.1007/s12630-023-02557-5 -
The Journal of Pharmacy Technology :... Aug 2023Anxiety is a condition for which current treatments are often limited by adverse events (AEs). Components of medicinal cannabis, cannabidiol (CBD) and...
The Effectiveness and Adverse Events of Cannabidiol and Tetrahydrocannabinol Used in the Treatment of Anxiety Disorders in a PTSD Subpopulation: An Interim Analysis of an Observational Study.
Anxiety is a condition for which current treatments are often limited by adverse events (AEs). Components of medicinal cannabis, cannabidiol (CBD) and tetrahydrocannabinol (THC), have been proposed as potential treatments for anxiety disorders, specifically posttraumatic stress disorder (PTSD). To evaluate quality-of-life outcomes after treatment with various cannabis formulations to determine the effectiveness and associated AEs. An interim analysis of data collected between September 2018 and June 2021 from the CA Clinics Observational Study. Patient-Reported Outcomes Measurement Information System-29 survey scores of 198 participants with an anxiety disorder were compared at baseline and after treatment with medicinal cannabis. The data of 568 anxiety participants were also analyzed to examine the AEs they experienced by the Medical Dictionary for Regulatory Activities organ system class. The median doses taken were 50.0 mg/day for CBD and 4.4 mg/day for THC. The total participant sample reported significantly improved anxiety, depression, fatigue, and ability to take part in social roles and activities. Those who were diagnosed with PTSD (n = 57) reported significantly improved anxiety, depression, fatigue, and social abilities. The most common AEs reported across the whole participant cohort were dry mouth (32.6%), somnolence (31.3%), and fatigue (18.5%), but incidence varied with different cannabis formulations. The inclusion of THC in a formulation was significantly associated with experiencing gastrointestinal AEs; specifically dry mouth and nausea. Formulations of cannabis significantly improved anxiety, depression, fatigue, and the ability to participate in social activities in participants with anxiety disorders. The AEs experienced by participants are consistent with those in other studies.
PubMed: 37529155
DOI: 10.1177/87551225231180796 -
PloS One 2023Developmental disabilities and neuromotor delay adversely affect long-term neuromuscular function and quality of life. Current evidence suggests that early therapeutic...
Protocol for a randomized controlled trial to evaluate a year-long (NICU-to-home) evidence-based, high dose physical therapy intervention in infants at risk of neuromotor delay.
INTRODUCTION
Developmental disabilities and neuromotor delay adversely affect long-term neuromuscular function and quality of life. Current evidence suggests that early therapeutic intervention reduces the severity of motor delay by harnessing neuroplastic potential during infancy. To date, most early therapeutic intervention trials are of limited duration and do not begin soon after birth and thus do not take full advantage of early neuroplasticity. The Corbett Ryan-Northwestern-Shirley Ryan AbilityLab-Lurie Children's Infant Early Detection, Intervention and Prevention Project (Project Corbett Ryan) is a multi-site longitudinal randomized controlled trial to evaluate the efficacy of an evidence-based physical therapy intervention initiated in the neonatal intensive care unit (NICU) and continuing to 12 months of age (corrected when applicable). The study integrates five key principles: active learning, environmental enrichment, caregiver engagement, a strengths-based approach, and high dosage (ClinicalTrials.gov identifier NCT05568264).
METHODS
We will recruit 192 infants at risk for neuromotor delay who were admitted to the NICU. Infants will be randomized to either a standard-of-care group or an intervention group; infants in both groups will have access to standard-of-care services. The intervention is initiated in the NICU and continues in the infant's home until 12 months of age. Participants will receive twice-weekly physical therapy sessions and caregiver-guided daily activities, assigned by the therapist, targeting collaboratively identified goals. We will use various standardized clinical assessments (General Movement Assessment; Bayley Scales of Infant and Toddler Development, 4th Edition (Bayley-4); Test of Infant Motor Performance; Pediatric Quality of Life Inventory Family Impact Module; Alberta Infant Motor Scale; Neurological, Sensory, Motor, Developmental Assessment; Hammersmith Infant Neurological Examination) as well as novel technology-based tools (wearable sensors, video-based pose estimation) to evaluate neuromotor status and development throughout the course of the study. The primary outcome is the Bayley-4 motor score at 12 months; we will compare scores in infants receiving the intervention vs. standard-of-care therapy.
Topics: Infant, Newborn; Child; Humans; Infant; Intensive Care Units, Neonatal; Quality of Life; Physical Therapy Modalities; Alberta; Allied Health Personnel; Randomized Controlled Trials as Topic
PubMed: 37725613
DOI: 10.1371/journal.pone.0291408 -
American Heart Journal Oct 2023Identifying and targeting established modifiable risk factors has been a successful strategy for reducing the burden of coronary artery disease (CAD) at the...
Incorporating a polygenic risk score-triaged coronary calcium score into cardiovascular disease examinations to identify subclinical coronary artery disease (ESCALATE): Protocol for a prospective, nonrandomized implementation trial.
BACKGROUND
Identifying and targeting established modifiable risk factors has been a successful strategy for reducing the burden of coronary artery disease (CAD) at the population-level. However, up to 1-in-4 patients who present with ST elevation myocardial infarction do so in the absence of such risk factors. Polygenic risk scores (PRS) have demonstrated an ability to improve risk prediction models independent of traditional risk factors and self-reported family history, but a pathway for implementation has yet to be clearly identified. The aim of this study is to examine the utility of a CAD PRS to identify individuals with subclinical CAD via a novel clinical pathway, triaging low or intermediate absolute risk individuals for noninvasive coronary imaging, and examining the impact on shared treatment decisions and participant experience.
TRIAL DESIGN
The ESCALATE study is a 12-month, prospective, multicenter implementation study incorporating PRS into otherwise standard primary care CVD risk assessments, to identify patients at increased lifetime CAD risk for noninvasive coronary imaging. One-thousand eligible participants aged 45 to 65 years old will enter the study, which applies PRS to those considered low or moderate 5-year absolute CVD risk and triages those with CAD PRS ≥80% for a coronary calcium scan. The primary outcome will be the identification of subclinical CAD, defined as a coronary artery calcium score (CACS) >0 Agatston units (AU). Multiple secondary outcomes will be assessed, including baseline CACS ≥100 AU or ≥75th age-/sex-matched percentile, the use and intensity of lipid- and blood pressure-lowering therapeutics, cholesterol and blood pressure levels, and health-related quality of life (HRQOL).
CONCLUSION
This novel trial will generate evidence on the ability of a PRS-triaged CACS to identify subclinical CAD, as well as subsequent differences in traditional risk factor medical management, pharmacotherapy utilization, and participant experience.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry, ACTRN12622000436774. Trial was prospectively registered on March 18, 2022. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383134.
Topics: Humans; Middle Aged; Aged; Coronary Artery Disease; Cardiovascular Diseases; Calcium; Prospective Studies; Quality of Life; Triage; Australia; Risk Factors; Risk Assessment; Coronary Angiography; Multicenter Studies as Topic
PubMed: 37364748
DOI: 10.1016/j.ahj.2023.06.009 -
Journal of Public Health Management and...Health departments (HDs) work on the front lines to ensure the health of their communities, providing a unique perspective to public health response activities. Say Yes!...
CONTEXT
Health departments (HDs) work on the front lines to ensure the health of their communities, providing a unique perspective to public health response activities. Say Yes! COVID Test (SYCT) is a US federally funded program providing free COVID-19 self-tests to communities with high COVID-19 transmission, low vaccination rates, and high social vulnerability. The collaboration with 9 HDs was key for the program distribution of 5.8 million COVID-19 self-tests between March 31 and November 30, 2021.
OBJECTIVE
The objective of this study was to gather qualitative in-depth information on the experiences of HDs with the SYCT program to better understand the successes and barriers to implementing community-focused self-testing programs.
DESIGN
Key informant (KI) interviews.
SETTING
Online interviews conducted between November and December 2021.
PARTICIPANTS
Sixteen program leads representing 9 HDs were purposefully sampled as KIs. KIs completed 60-minute structured interviews conducted by one trained facilitator and recorded.
MAIN OUTCOME MEASURES
Key themes and lessons learned were identified using grounded theory.
RESULTS
Based on perceptions of KIs, HDs that maximized community partnerships for test distribution were more certain that populations at a higher risk for COVID-19 were reached. Where the HD relied predominantly on direct-to-consumer distribution, KIs were less certain that communities at higher risk were served. Privacy and anonymity in testing were themes linked to higher perceived community acceptance. KIs reported that self-test demand and distribution levels increased during higher COVID-19 transmission levels.
CONCLUSION
HDs that build bridges and engage with community partners and trusted leaders are better prepared to identify and link high-risk populations with health services and resources. When collaborating with trusted community organizations, KIs perceived that the SYCT program overcame barriers such as mistrust of government intervention and desire for privacy and motivated community members to utilize this resource to protect themselves against COVID-19.
Topics: Humans; COVID-19; Self-Testing; COVID-19 Testing; Grounded Theory; Public Health
PubMed: 36729971
DOI: 10.1097/PHH.0000000000001688 -
Archives of Disease in Childhood. Fetal... Sep 2023Assess mortality and neurodevelopmental outcomes at 2 years of corrected age in children who participated in the PlaNeT-2/MATISSE (Platelets for Neonatal Transfusion -...
OBJECTIVE
Assess mortality and neurodevelopmental outcomes at 2 years of corrected age in children who participated in the PlaNeT-2/MATISSE (Platelets for Neonatal Transfusion - 2/Management of Thrombocytopenia in Special Subgroup) study, which reported that a higher platelet transfusion threshold was associated with significantly increased mortality or major bleeding compared to a lower one.
DESIGN
Randomised clinical trial, enrolling from June 2011 to August 2017. Follow-up was complete by January 2020. Caregivers were not blinded; however, outcome assessors were blinded to treatment group.
SETTING
43 level II/III/IV neonatal intensive care units (NICUs) across UK, Netherlands and Ireland.
PATIENTS
660 infants born at less than 34 weeks' gestation with platelet counts less than 50×10/L.
INTERVENTIONS
Infants were randomised to undergo a platelet transfusion at platelet count thresholds of 50×10/L (higher threshold group) or 25×10/L (lower threshold group).
MAIN OUTCOMES MEASURES
Our prespecified long-term follow-up outcome was a composite of death or neurodevelopmental impairment (developmental delay, cerebral palsy, seizure disorder, profound hearing or vision loss) at 2 years of corrected age.
RESULTS
Follow-up data were available for 601 of 653 (92%) eligible participants. Of the 296 infants assigned to the higher threshold group, 147 (50%) died or survived with neurodevelopmental impairment, as compared with 120 (39%) of 305 infants assigned to the lower threshold group (OR 1.54, 95% CI 1.09 to 2.17, p=0.017).
CONCLUSIONS
Infants randomised to a higher platelet transfusion threshold of 50×10/L compared with 25×10/L had a higher rate of death or significant neurodevelopmental impairment at a corrected age of 2 years. This further supports evidence of harm caused by high prophylactic platelet transfusion thresholds in preterm infants.
TRIAL REGISTRATION NUMBER
ISRCTN87736839.
Topics: Infant; Child; Infant, Newborn; Humans; Child, Preschool; Infant, Premature; Platelet Transfusion; Hemorrhage; Thrombocytopenia; Gestational Age
PubMed: 36810309
DOI: 10.1136/archdischild-2022-324915